Safety, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Patients With Type 2 Diabetes Mellitus and Healthy Adults

• ClinicalTrials.gov Identifier: NCT01042106
• Recruitment Status: Completed
• First Posted: January 5, 2010
• Last Update Posted: September 16, 2013
• Sponsor: Sunovion
• Information provided by (Responsible Party): Sunovion

Tracking Information

• First Submitted Date: December 21, 2009
• First Posted Date: January 5, 2010
• Last Update Posted Date: September 16, 2013
• Study Start Date: November 2009
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 3, 2010): Safety assessments include physical examination, laboratory variables and ECG. [ Time Frame: 20 days ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 3, 2010)

• Pharmacokinetics of DSP-8658 and its metabolites: levels of DSP-8658 and its metabolites will be measured and analyzed at various time points throughout the study. [ Time Frame: 20 days ]
• Pharmacodynamics of DSP-8658 (how DSP-8658 acts in the body to affect glucose and lipid control): glucose and lipid levels will be measured at various time points throughout the study. [ Time Frame: 18 days ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Patients With Type 2 Diabetes Mellitus and Healthy Adults
• Official Title: A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Oral Dose Study to Evaulate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Type 2 Diabetic and Healthy Subjects
• Brief Summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of DSP-8658 in patients with Type 2 diabetes mellitus and healthy adults.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Type 2 Diabetes Mellitus

Intervention

• Drug: DSP-8658
  Ascending doses of DSP-8658 - 2.5, 10, 20, 40 mg orally once daily
• Drug: Placebo
  Placebo 2.5, 10, 20, 40 mg orally once daily

Study Arms

• Experimental: DSP-8658
  DSP-8658 2.5, 10, 20, 40 mg once daily
  Intervention: Drug: DSP-8658
• Placebo Comparator: Placebo
  Placebo 2.5, 10, 20, and 40 mg doses once daily
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 3, 2010): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2010
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria: Diabetic subjects

• Age ≥ 18 and ≤ 65 years
• Body Mass Index ≤45
• Drug naive type 2 diabetes or type 2 diabetes previously treated with an oral antidiabetic drug

Inclusion Criteria: Healthy subjects

• Age ≥ 18 and ≤ 65 years
• Body Mass Index ≥ 18 and ≤ 29
• Good health as determined by medical history, ECG, clinical chemistry, hematology, urinalysis, virology, and a physical examination.

Exclusion Criteria: Diabetic subjects

• Have a current or expected requirement for any antidiabetic or lipid-lowering drug

Exclusion Criteria: Healthy subjects

• Have, or have had a history of clinically significant neurological, urological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders including cancer

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01042106
• Other Study ID Numbers: D6950153
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Sunovion
• Study Sponsor: Sunovion
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director, MD; Sunovion

• PRS Account: Sunovion
• Verification Date: September 2013